Knee OsteoarthritisNCT06430918
Neuropathic Pain and it's Relation to Sleep Quality in Knee Osteoarthritis
An observational study of Knee Osteoarthritis and Sleep Disturbance, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The primary aim is to investigate the frequency and severity of neuropathic pain and its association with night pain in patients with knee osteoarthritis. For this purpose a progressive longitudinal study design was planned. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Knee Osteoarthritis, Sleep Disturbance, Neuropathic Pain
- What is being tested?
- physical examination, questionnaires and inventories
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 May 2024to 30 Jul 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stage 2-4 knee OA will be evaluated in terms of demographic variables and outcome measurement parameters specified in the case report form.
Who may be able to join
- 1. Having a clinical diagnosis of knee osteoarthritis according to the American Rheumatology Association/ACR criteria 2. Knee OA is of Kellgren-Lawrence stage 2-4 3. The participant gives signed consent
- -
Who cannot join
- 1. Having diabetes mellitus 2. Chronic kidney failure 3. Hypothyroidism 4. Presence of orthopedic disability (such as implant, prosthesis, contracture, shortness) in the lower extremity 4. Neurological diseases that can cause neuropathic pain 5. Presence of fibromyalgia 6. Malignancy 7. Pregnancy 8. Neurological deficit in the lower extremity 9. Drug use that may cause neuropathy (colchicine, etc.) İn the last 3 months 10. Drug use (antidepressant, antipsychotic, antiepileptic) due to sleep disturbance or widespread pain in the last 3 months.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Izmir Bozyaka Training and Reseach Hospital
Izmir, 35300
About this study
Official title: Coexistence of Night Pain and Neuropathic Pain in Patients With Knee Osteoarthritis
The primary aim is to investigate the frequency and severity of neuropathic pain and its association with night pain in patients with knee osteoarthritis. For this purpose a progressive longitudinal study design was planned. The secondary aim is to investigate the relationship between night pain and neuropathic pain and sleep quality.
Read the detailed description
Osteoarthritis (OA) is the most common form of arthritis in the world. Classically, OA presents with joint pain and loss of function; however, the disease is clinically very variable and can present merely as an asymptomatic incidental finding to a devastating and permanently disabling disorder.
The severity of knee pain caused by osteoarthritis, often does not correlate with the degree of degenerative changes in the joint. In patients reporting night pain, this may be related to inflammation, but in the absence of clinical and laboratory findings of inflammation, it is not possible to explain night pain only by the degree of joint damage. The existence of a relationship between night pain and neuropathic pain may be a guide in looking for neuropathic pain in patients who have night pain and experience this pain severely and thus for planning an appropriate treatment for the patient.
Patients with stage 2-4 knee OA will be evaluated in terms of demographic variables and outcome measurement parameters specified in the case report form. The relationship between neuropathic pain scores and knee pain severity will be sought. It will be studied whether there is a difference in outcome measurement parameters between those with neuropathic pain and those without. Correlation analysis will be performed between sleep quality score and pain intensity scores. The determinants of sleep quality will be evaluated by regression analysis.
American College of Rheumatology criteria will be recruited. Demographics and disease related variables will be recorded.
- Conditions
- Knee Osteoarthritis, Sleep Disturbance, Neuropathic Pain
- Being tested
- physical examination, questionnaires and inventories
- Medical subject headings
- Osteoarthritis, Knee, Parasomnias, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical examination, questionnaires and inventoriesOther
Also called Questionnaires and inventories related to primary end secondary outcomes will be applied and physical examination will be performed.
Questionnaires and inventories related to primary end secondary outcomes will be applied and physical examination will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Patients with knee osteoarthritis | Knee OA patients diagnosed according to the ACR Classification Criteria Receives: Other: physical examination, questionnaires and inventories |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropathic pain; 4 Questions Neuropathic Pain Questionnaire
The DN4 questionnaire (4 Questions Neuropathic Pain Questionnaire) will be used. It is a clinician-administered questionnaire. It consists of ten items. Seven items related to pain quality (i.e. sensory and pain descriptors) are based on an interview with the patient. Three items are based on the clinical examination. The clinician assesses whether there is reduced sensation (hyposthesia) to touch or pinprick and whether light brushing increases or causes pain (allodynia). All of the positive items are scored as one point and total score is sum of the scores of these positive items. The diagnosis is based on 4/10 cut-off value.
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
Sleep quality
Jenkins Sleep Scale.The four-item questionnaire evaluates the frequency and intensity of certain sleep difficulties in respondents. Questions queries the number of days in which the patient was subjected to sleep problems. The maximum possible score is 20 and higher scores indicate much more sleep disturbance. A mean score of two or more is considered as sleep disturbance presence.
Measured: through study completion, an average of 1 year
Depression and Anxiety; The Hospital Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale (HADS) was developed by Zigmond and Snaith in 1983. It is used to detect whether the patient is in the depressive or anxious status. It is not a diagnostic tool but gives to physician an idea about the patient's emotional status. It consists of fourteen items. Seven items are related to anxiety and the other seven depression
Measured: through study completion, an average of 1 year
Quality of life level; KOOS (KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE) "Quality of Life" subgroup
KOOS evaluates the symptoms and functional problems related to knee OA and knee injury. It consists of five subscales. In this study authors intended to assess the life quality by using the quality of life level subscale of this scale.
Measured: through study completion, an average of 1 year
Disability; KOOS (KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE) "Activities of Daily Life and Function" subgroup
Disability; KOOS (KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE) "Activities of Daily Life and Function" subgroup
Measured: through study completion, an average of 1 year
Night pain (VAS, 0-10 cm) Participants will be asked to report the pain intensity that they feel on a line between 0 and 10, higher scores indicating more intense pain.
Participants will be asked to report the pain intensity that they feel on a line between 0 and 10, higher scores indicating more intense pain.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start16 May 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Bozyaka Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taciser Kaya, Bozyaka Training and Research Hospital
- Investigators
- Taciser Kaya, Prof., Principal investigator, Izmir Bozyaka Training and Research Hospital İzmir, TurkeyBerna Kirilmaz Colak, MD, Principal investigator, Izmir Bozyaka Training and Research Hospital İzmir, TurkeyBugra Ince, Assoc. prof., Principal investigator, Izmir Bozyaka Training and Research Hospital İzmir, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06430918
- Sponsor's protocol ID
- 226092BK
- Status last verified
- Nov 2025
- First submitted
- 17 May 2024
- Last updated
- 14 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hoper J, Schraml L, Gierthmuhlen J, Helfert SM, Rehm S, Hartig S, Schroder O, Lankes M, Traulsen FC, Seekamp A, Baron R. Changes of Somatosensory Phenotype in the Course of Disease in Osteoarthritis Patients. Int J Environ Res Public Health. 2020 Apr 29;17(9):3085. doi: 10.3390/ijerph17093085.
PubMed 32365479Wylde V, Palmer S, Learmonth ID, Dieppe P. Somatosensory abnormalities in knee OA. Rheumatology (Oxford). 2012 Mar;51(3):535-43. doi: 10.1093/rheumatology/ker343. Epub 2011 Nov 24.
PubMed 22120461
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coexistence of Night Pain and Neuropathic Pain in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06430918
- Acronym / sponsor ID
- 226092BK
- Conditions
- Knee Osteoarthritis, Sleep Disturbance, Neuropathic Pain
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Bozyaka Training and Research HospitalUniversity, hospital or other
- Study start
- 16 May 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 28 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim is to investigate the frequency and severity of neuropathic pain and its association with night pain in patients with knee osteoarthritis. For this purpose a progressive longitudinal study design was planned. The secondary aim is to investigate the relationship between night pain and neuropathic pain and sleep quality.
Detailed description
Osteoarthritis (OA) is the most common form of arthritis in the world. Classically, OA presents with joint pain and loss of function; however, the disease is clinically very variable and can present merely as an asymptomatic incidental finding to a devastating and permanently disabling disorder.
The severity of knee pain caused by osteoarthritis, often does not correlate with the degree of degenerative changes in the joint. In patients reporting night pain, this may be related to inflammation, but in the absence of clinical and laboratory findings of inflammation, it is not possible to explain night pain only by the degree of joint damage. The existence of a relationship between night pain and neuropathic pain may be a guide in looking for neuropathic pain in patients who have night pain and experience this pain severely and thus for planning an appropriate treatment for the patient.
Patients with stage 2-4 knee OA will be evaluated in terms of demographic variables and outcome measurement parameters specified in the case report form. The relationship between neuropathic pain scores and knee pain severity will be sought. It will be studied whether there is a difference in outcome measurement parameters between those with neuropathic pain and those without. Correlation analysis will be performed between sleep quality score and pain intensity scores. The determinants of sleep quality will be evaluated by regression analysis.
American College of Rheumatology criteria will be recruited. Demographics and disease related variables will be recorded.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with knee osteoarthritis | – | Other: physical examination, questionnaires and inventoriesKnee OA patients diagnosed according to the ACR Classification Criteria |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stage 2-4 knee OA will be evaluated in terms of demographic variables and outcome measurement parameters specified in the case report form.
Key inclusion criteria (2 listed)
- 1. Having a clinical diagnosis of knee osteoarthritis according to the American Rheumatology Association/ACR criteria 2. Knee OA is of Kellgren-Lawrence stage 2-4 3. The participant gives signed consent
- -
Key exclusion criteria (2 listed)
- 1. Having diabetes mellitus 2. Chronic kidney failure 3. Hypothyroidism 4. Presence of orthopedic disability (such as implant, prosthesis, contracture, shortness) in the lower extremity 4. Neurological diseases that can cause neuropathic pain 5. Presence of fibromyalgia 6. Malignancy 7. Pregnancy 8. Neurological deficit in the lower extremity 9. Drug use that may cause neuropathy (colchicine, etc.) İn the last 3 months 10. Drug use (antidepressant, antipsychotic, antiepileptic) due to sleep disturbance or widespread pain in the last 3 months.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical examination, questionnaires and inventoriesAlso: Questionnaires and inventories related to primary end secondary outcomes will be applied and physical examination will be performed.Questionnaires and inventories related to primary end secondary outcomes will be applied and physical examination will be performed. | Other | Patients with knee osteoarthritis |
Primary outcome
Neuropathic pain; 4 Questions Neuropathic Pain Questionnaire
Time frame: through study completion, an average of 1 year
The DN4 questionnaire (4 Questions Neuropathic Pain Questionnaire) will be used. It is a clinician-administered questionnaire. It consists of ten items. Seven items related to pain quality (i.e. sensory and pain descriptors) are based on an interview with the patient. Three items are based on the clinical examination. The clinician assesses whether there is reduced sensation (hyposthesia) to touch or pinprick and whether light brushing increases or causes pain (allodynia). All of the positive items are scored as one point and total score is sum of the scores of these positive items. The diagnosis is based on 4/10 cut-off value.
5 secondary outcomes
Sleep quality
Time frame: through study completion, an average of 1 year
Depression and Anxiety; The Hospital Anxiety and Depression Scale (HADS)
Time frame: through study completion, an average of 1 year
Quality of life level; KOOS (KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE) "Quality of Life" subgroup
Time frame: through study completion, an average of 1 year
Disability; KOOS (KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE) "Activities of Daily Life and Function" subgroup
Time frame: through study completion, an average of 1 year
Night pain (VAS, 0-10 cm) Participants will be asked to report the pain intensity that they feel on a line between 0 and 10, higher scores indicating more intense pain.
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
- Results publication: PubMed 32365479Hoper J, Schraml L, Gierthmuhlen J, Helfert SM, Rehm S, Hartig S, Schroder O, Lankes M, Traulsen FC, Seekamp A, Baron R. Changes of Somatosensory Phenotype in the Course of Disease in Osteoarthritis Patients. Int J Environ Res Public Health. 2020 Apr 29;17(9):3085. doi: 10.3390/ijerph17093085.
- Results publication: PubMed 22120461Wylde V, Palmer S, Learmonth ID, Dieppe P. Somatosensory abnormalities in knee OA. Rheumatology (Oxford). 2012 Mar;51(3):535-43. doi: 10.1093/rheumatology/ker343. Epub 2011 Nov 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Taciser Kaya, Prof. principal investigator
Izmir Bozyaka Training and Research Hospital İzmir, Turkey
Berna Kirilmaz Colak, MD principal investigator
Izmir Bozyaka Training and Research Hospital İzmir, Turkey
Bugra Ince, Assoc. prof. principal investigator
Izmir Bozyaka Training and Research Hospital İzmir, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis and Sleep Disturbance, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropathic pain; 4 Questions Neuropathic Pain Questionnaire (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06430918, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025.